FSP - Regulatory Affairs Project and Data Manager

We are currently looking for a client dedicated Regulatory Affairs Senior Associate who will act as a Regulatory Project and Data Manager (RPDM) .

In this you will work closely with Regulatory Matrix Teams and Early/Medicine Development Teams to provide Regulatory functional line planning support and resource management to active Rx and Vx projects, spanning Commit to Candidate (C2C) through post-approval R&D activities. You will own and provide active management of integrated Regulatory Development Plans. These plans will reflect the Global Regulatory Strategy for individual Vx and Rx projects. You will work alongside a more senior Regulatory Portfolio Manager to create the Plans, after which you will work independently to maintain the plans, ensuring they continue to reflect the Global Regulatory Strategy as it evolves over time. This includes adding appropriate Regulatory deliverables, updating timelines, manipulating the interdependencies and logic in the plan to ensure accurate timelines that drive key Regulatory milestones.

This role can be based in Poland, UK, Belgium or Italy - office or home based.

Key Responsibilities:

Independently use judgement, strict adherence to quality and process expectations, industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans (RDPs) based on input from GRLs and project teams on the overall development strategies associated with projects (asset by indication)

Responsible for maintaining integrated Regulatory Development Plan (RDP) for operationalizing the Global Regulatory Strategy (as defined by the GRL), ensuring regulatory deliverables, timelines, and resource needs are accurately captured for each phase of development

Provide Regulatory functional line planning support at the project level

Perform scenario planning through developing alternative planning schedules, for development team and portfolio decision making

Proactively partner with other functional plan owners/project managers from Medical, Safety, Clinical, etc., to ensure awareness of regulatory deliverables and alignment across all plan types within a project group

Support R&D Governance reviews at key stage gates in the development process; Ensure any requested data is complete, accurate, and fit for purpose for informing business decisions

With support from line managers/RPMs, as needed, build the associated schedules to drive Regulatory resource forecast estimates; forecast cost (EPE) and resource (FTE/IPE) associated with integrated plans

Partner with key stakeholders including RMT members and functional Project Managers, etc. to ensure plan schedule alignment to intended strategy

Skills and Experience required for the role:

University degree

5 years of experience understanding of pharmaceutical business, drug development, and project management

Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives

Ideally possessing knowledge of Regulatory Affairs responsibilities from pre-IND through post-approval Experience with project management principles and systems (e.g. Planisware), resource management and reporting features (e.g. Spotfire)

Demonstrated experience in a range of role essential skills (e.g., data analysis, problem resolution, enterprise-wide project management tools)

Ability to present data and visualizations based on the needs of the target audience

Project management experience, preferably in the pharmaceutical industry or in a regulatory environment

Fluent in English

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